Company*

Product

Description

Indication

Status

(Symbol)

(Date)

CANCER

AVAX Technologies Inc. (AVXT)

M-Vax and O-Vax

Vaccines made from a patient's own cancer cells, modified with a hapten molecule that makes the tumor cells appear foreign to the patient's immune system to elicit a tumor-killing response

Melanoma and ovarian cancer

FDA commented in a letter the reasons the vaccines were put on clinical hold; the company expects to take three months to answer the FDA's questions (4/23)

BioTransplant Inc. (BTRN)

BCell-HDM Cell Separation System

Designed to eliminate potentially malignant B cells from autologous stem cell transplants

Non-Hodgkin's lymphoma

Company, with merger partner Eligix Inc., received FDA clearance to initiate a pivotal Phase III trial (4/30)

Ilex Oncology Inc. (ILXO) and Millennium Pharmaceuticals Inc. (MLNM)

Campath

Alemtuzumab; humanized monoclonal antibody

Chronic lymphocytic leukemia

FDA said it will take action on the BLA in May (4/6)

Vysis Inc. (VYSI) and Genentech Inc. (NYSE:DNA)

Path Vysion HER-2 test

Determines which patients are candidates for Genentech's Herceptin (trastuzumab) therapy

Cancer

Companies filed a PMA for use of the test to determine which breast cancer patients are candidates for Genentech's Herceptin therapy (4/2)

CARDIOVASCULAR

Scios Inc. (SCIO)

Natrecor

Nesitritide; recombinant form of B-type natriuretic peptide

Congestive heart failure

FDA's Cardiovascular and Renal Drugs Advisory Committee will review the NDA on May 25 (4/10)

United Therapeutics Corp. (UTHR)

Remodulin (formerly UT-15)

Prostacyclin analogue

Pulmonary arterial hypertension

FDA extended for up to 90 days the priority review period for the NDA, allowing the FDA to review additional information submitted (4/15)

CENTRAL NERVOUS SYSTEM

Amgen Inc. (AMGN)

Kineret

Interleukin-1 receptor antagonist; anakinra

Rheumatoid arthritis

Company submitted more information to the FDA to support its 1999 BLA filing (4/23)

Celltech Pharmaceuticals Inc. (unit of the Celltech Group plc; UK; NYSE:CLL; LSE:CCH)

Metadate CD

Methylphenidate HCl extended-release 20 mg capsules

Attention deficit hyperactivity disorder

FDA granted marketing approval to treat patients 6 years or older (4/4)

Orphan Medical Inc. (ORPH)

Xyrem

Sodium oxybate oral solution

Narcolepsy

FDA rescheduled an advisory committee review to June 6 (4/12)

INFECTION

VaxGen Inc. (VXGN)

AIDSVAX

Made from a synthetic protein; AIDS vaccine

AIDS

A fifth review by the Data and Safety Monitoring Board found the AIDS vaccine still safe after 23,000 vaccine injections in Phase III trials (4/13)

MISCELLANEOUS

Isotechnika Inc. (Canada; VSE:ISA)

ISAtx247

Immunosuppressive agent based on cyclosporine

Kidney transplantation

Company filed applications with the FDA and Canadian authorities to begin Phase II trials (4/12)

Genelabs Technologies Inc. (GNLB)

Aslera

Orally administered, highly purified prasterone, which is the synthetic equivalent of dehydroepiandrosterone

Lupus

FDA's Arthritis Advisory Committee met, but did not vote on whether to recommend approval of the NDA (4/19)

Organogenesis Inc. (AMEX:ORG)

Fortaflex technology

Engineered collagen technology designed for internal repair applications

Soft tissue repair and wound dressing

Company submitted three marketing applications for Fortagen and Fortaperm to repair soft tissue, and Fortaderm for wound dressing (4/16)

Ortec International Inc. (ORTC)

Composite cultured skin

Cryopreserved (frozen) version of CCS

Burns

FDA accepted the PMA (4/4)

Notes:

* Privately held

Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.

AMEX = American Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; VSE = Vancouver Stock Exchange

BLA = Biologics License Application; NDA = New Drug Application; PMA = Premarket Approval Application

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